Condition category
Urological and Genital Diseases
Date applied
15/07/2011
Date assigned
29/09/2011
Last edited
28/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The testes are housed in the scrotum because the scrotum is a few degrees cooler than the core body temperature, which forms the best environment for sperm production. This study aims to find out whether exposing the scrotum to lower temperatures using a cooling patch improves the fertility of men who have abnormal sperm counts.

Who can participate?
Any man above the age of 18 who has an abnormal sperm count.

What does the study involve?
Participants are randomly allocated to one of two groups. Men in one group wear the cooling patch for 8 hours per day for a period of 90 consecutive days. Men in the other group do not wear the patch. In order to determine if there is an improvement we test the participants’ sperm count at the start and the end of the study.

What are the possible benefits and risks of participating?
To date we do not know of any risks as the cooling patch has been tested and proven to be safe.

Where is the study run from?
Nottingham University Hospitals (UK).

When is the study starting and how long is it expected to run for?
August 2011 to May 2012.

Who is funding the study?
University of Nottingham (UK).

Who is the main contact?
Mr William Atiomo (william.atiomo@nottingham.ac.uk)
Dr Ilias Nikolopoulos (illias.nikolopolous@nuh.nhs.uk)
Dr Waseem Osman (Mohammed.Osman@nuh.nhs.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Mr William Atiomo

ORCID ID

Contact details

Nottingham University Hospitals
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EM 11024

Study information

Scientific title

A pilot randomised study of the effects of the FertilMate - a scrotal cooling patch on male fertility

Acronym

SCOP

Study hypothesis

To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility

Ethics approval

NRES Committee East Midlands - Nottingham 2, 27/05/2011, ref: 11/EM/0163

Study design

Randomised control trial pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Reproductive Medicine

Intervention

1. Scrotal cooling patch worn by the study group
2. Semen analyses on all 40 participants on day 0 and day 90
3. Serum Metabolomics tested by means of 1x 20ml blood sample

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility
2. The main parameter will be a change to sperm count, quality and concentration
3. Improvements to sperm motility and morphology

Secondary outcome measures

Scrotal bloodflow

Overall trial start date

01/08/2011

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males
2. Aged 18 to 45 years of age

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

40, 20 in the study group and 20 in the control group

Participant exclusion criteria

1. Candidates who have undergone a vasectomy
2. Candidates who have an allergy to menthol
3. Males aged below 18 and older than 45 years on age
4. We will not be recruiting individuals that are unable to consent for themselves and nor will we be including participants who are from vulnerable groups

Recruitment start date

01/08/2011

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Mr Paul Cartledge
University of Nottingham
University Park
Nottingham
NG7 2 RD
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22540417

Publication citations

  1. Protocol

    Osman MW, Nikolopoulos L, Haoula Z, Kannamannadiar J, Atiomo W, A study of the effect of the FertilMate™ Scrotum Cooling Patch on male fertility. SCOP trial (scrotal cooling patch) - study protocol for a randomised controlled trial., Trials, 2012, 13, 47, doi: 10.1186/1745-6215-13-47.

Additional files

Editorial Notes